ExpreS2ion updates on its pipeline outlook, including for COVID-19 and HER2 breast cancer projects

Hørsholm, Denmark, March 16, 2021 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") today presents an updated outlook for its pipeline development projects, including the ABNCoV2 COVID-19 vaccine and its ES2B-C001 HER2-cVLP breast cancer vaccine. The update is published ahead of a digital company presentation to be held today at 11.00 CET, during which CEO Bent U. Frandsen will discuss the promising outlook of ExpreS2ion’s project pipeline in more detail.

CEO Bent U. Frandsen comments

“We have already seen great progress for ExpreS²ion in 2021, with the initiation of a phase I/II trial for the ABNCoV2 COVID-19 vaccine and the in-licensing and successful selection of a lead candidate in our ES2B-C001 HER2-cVLP breast cancer vaccine project. I am truly excited for the future of ExpreS²ion, as we continue to build strong value in our growing pipeline with an impressive mix of inhouse and collaboration projects for high-profile indications, also including influenza and various stages of malaria.”

To digitally attend today’s company presentation by CEO Bent U. Frandsen, reserve a seat at Aktiespararna's website. The presentation will also be made available for later viewing.

Below, updated summaries of recently achieved and upcoming expected milestones, as well as additional information of interest for the future outlook, are presented per project or indication. A pipeline chart, outlining the progress of each project, can be viewed on https://expres2ionbio.com/pipeline/.

The ABNCoV2 COVID-19 vaccine        

• The initiation of a first-in-human phase I/II open label dose escalation clinical trial, supported by the Horizon 2020 EU grant, was announced on March 8, 2021.          
• Following the initiation of the trial, the first-in-human dose was administered on March 15, 2021. Initial safety data from the study is expected in Q1 2021 and will be announced in April.
• Headline results from the study are expected by the end of June 2021.

The exclusive global licensee Bavarian Nordic, responsible for the clinical program and the commercialization of ABNCoV2, completed a directed issue and private placement of DKK 1.1 billion on March 10, 2021, of which approximately DKK 200 million, corresponding to SEK 270 million, will support an additional phase I/II clinical trial and scale-up of the manufacturing.

The ES2B-C001 HER2-cVLP breast cancer vaccine    

• After in-licensing the project from AdaptVac in February 2021, thus securing 100% control of the project, ExpreS²ion rapidly generated its own vaccine candidate ES2B-C001, which has a solid preliminary biophysical profile.
• On February 23, the signing of a research collaboration agreement with University of Bologna for preclinical studies was announced.
• Preclinical proof of concept data for ES2B-C001 is expected at the end of 2021.
• The clinical program is expected to start in 2022 with GMP manufacturing of ES2B-C001.

A clinical Phase I safety and immune response study is planned to start in Q1 2023. The study will explore key variables for immunization success. Based on the expected vaccine profile, ES2B-C001 is anticipated to replace current HER2-directed agents like trastuzumab and pertuzumab, both in metastatic and later adjuvant settings, leading to potential blockbuster sales scenarios.

The EU Horizon 2020-funded influenza vaccine program

• This next-generation influenza vaccine program, developed by the EU-India INDIGO consortium with ExpreS²ion as a member, received EUR 10 million in funding as announced in March 2020.
• The vaccine design is completed, and lead candidates have been selected. 
• Preclinical activities are planned to be being initiated later in 2021 at the Institut National de la Sante et de la Recherche Medicale (INSERM) in France.     
   

Malaria vaccine projects with academic collaboration partners        

• ExpreS²ion is involved in five malaria vaccine projects with different targets/objectives (three for blood-stage, one for transmission and one for placenta) 
• The academic partners for these projects, the University of Oxford and University of Copenhagen, have conveyed that new grant funding initiatives are being explored to progress on the clinical phase II (RH5, blood-stage malaria vaccine) and clinical phase I (VAR2CSA, placenta-borne malaria vaccine) projects, respectively.
• With additional funding being explored, and the academic partners able to reduce their focus on COVID-19, Increased activity is to be expected in these projects in 2021.

Certified Adviser

Svensk Kapitalmarknadsgranskning AB

Telefon: +46 11 32 30 732

E-post: ca@skmg.se

 

This press release constitutes inside information that ExpreS2ion Biotech Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was sent for publication, through the agency of the contact persons set out above, at the time stated by the Company’s news distributor, Cision, at the publication of this press release.

For further information about ExpreS²ion Biotech Holding AB, please contact:

Bent U. Frandsen, CEO
Telephone: +45 4256 6869
E-mail: buf@expres2ionbio.com

About ExpreS²ion

ExpreS²ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS²ion Biotech Holding AB with company register number 559033-3729. ExpreS²ion has developed a unique technology platform, ExpreS², for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS² is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 300 proteins and 40 virus-like particles (VLPs) in collaboration with leading research institutions and companies. Since 2017, ExpreS²ion develops novel VLP based vaccines through its joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com and www.adaptvac.com.

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